MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-05-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant products: 1.Carto xp system: model #: unknown, serial #: unknown; 2.Ep - shuttle rf generator system - 100w: model #: 39d-76x, serial #: st-2204.(b)(4).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.Manufacturer's ref.No: (b)(4).More distally by the physician to do further diagnostic testing.He was not able to venture distally due to anatomy of the coronary sinus not permitting as it may have been small or early bifurcation.No venogram was performed.Therefore, could not confirm.The outcome of the adverse event was improved.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.An additional request has been made to clarify if there were biosense webster catheters used during this procedure.However, no further information has been made available.Since the two ez steer thermocool navigational 4mm catheters were used during the procedure, biosense webster is taking a conservative approach and reporting this event under both these catheters used during the procedure.

Event Description

It was reported that a male patient that was in his 60's underwent a premature ventricular contraction (pvc) procedure with an ez steer thermocool navigational 4mm catheter and suffered a cardiac tamponade which required a pericardiocentesis.During the event, while using an ez steer thermocool navigational catheter, the catheter was not detected by the carto xp system.This catheter was replaced with another ez steer thermocool navigational catheter and the issue resolved.Also during ablation there was a hardware error 9.They reduced the power and continued with the procedure.Both these issues were not indicative of mdr reportable issues.Post procedure there was a pericardial effusion.The pericardial effusion was tapped and 200mls of blood were drained from the pericardial space.The patient's blood pressure recovered.The drain was removed the following day.No further issues were reported.The patient did not have a transseptal puncture performed.An 8.5 short sheath was used.However, the brand was not known.The generator was set to temperature mode.Therefore, it reached each individual set power of 40w, 35w, 30w and 20w in approximately 8 seconds.The flow was set to 30 ml/min when ablating at 30w and 17 ml/min when ablating at or below 30w.The ablation site was not confirmed as the site of "injury" as the blood pressure had been gradually dropping throughout procedure from the first diagnostic catheter insertion prior to first ablation.Ablation was for approximately 2 minutes in a region of approximately 2cm x 2cm.The coronary sinus catheter had been attempted to be maneuvered much.

Manufacturer Narrative

Additional information was received on october 15, 2015 stating that the product has been disposed of.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5120462
• MDR Text Key: 27413989
• Report Number: 2029046-2015-00232
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: UNKNOWN_D-1292-05-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 90